FDA applicant
Telectronics Pacing Systems, Inc.
FDA records 22 decisions for Telectronics Pacing Systems, Inc. (Englewood, CO) from 1983 to 1997: 20 510(k) clearances and 2 original PMA approvals. Most are in product codes DTB (Permanent Pacemaker Electrode) and DTD (Pacemaker Lead Adaptor). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Telectronics Pacing Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Telectronics Pacing Systems, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Telectronics Pacing Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Telectronics”
FDA records each applicant name separately; these may or may not be the same firm.